The FDA has approved Merck's supplemental marketing applications for HIV drugs Pifeltro (doravirine) and Delstrigo (doravirine, lamivudine and tenofovir disoproxil fumarate).
The approval allows treatment-experienced adults living with HIV, who are virally suppressed and have no prior history of treatment failure, to switch to either of the treatment options.
The FDA first approved both drugs in August 2018 for adult patients with no prior antiretroviral treatment experience.
“Today’s approvals provide doravirine treatment options for people living with HIV-1 who are virally suppressed, reflecting Merck’s continued commitment to research and development of HIV treatments,” said George Hanna, MD, vice president and therapeutic area head of infectious diseases, Global Clinical Development, Merck Research Laboratories.
Read the press release